BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD VACUTAINER® PLUS PLASTIC SST TUBE. GOLD BD HEMOGARD¿

    MDR report key: 7071449 · Received November 30, 2017

    Report

    Report Number
    1024879-2017-00763
    Event Type
    Malfunction
    Date Received
    November 30, 2017
    Date of Event
    June 20, 2016
    Report Date
    November 1, 2017
    Manufacturer
    BECTON, DICKINSON & CO., (BD)
    Product Code
    JKA
    UDI-DI
    00382903679867
    PMA / PMN Number
    K023075
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: BD RECEIVED (B)(4) SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR STOPPERS FALLING OFF WITH THE INCIDENT LOT WAS OBSERVED. A REVIEW OF THE MANUFACTURING RECORDS WAS COMPLETED FOR INCIDENT LOT 6050838 AND NO ISSUES WERE IDENTIFIED. CONCLUSION: THE ROOT CAUSE IS EXCESSIVE LUBRICANT APPLIED TO THE STOPPERS VIA SPRAYING INTO THE STOPPER BOWLS AND ONTO THE RAILS AND BY INADEQUATE CLEANING CONTRIBUTED TO THE STOPPERS CREEPING OUT OF TUBES. REFER TO CAPA (B)(4) FOR COMPLETE INVESTIGATION AND ACTION PLANS FOR THE REPORTED DEFECT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STOPPERS/CAPS FOR THE 5.0 ML BD VACUTAINER® PLUS PLASTIC SST TUBE FELL OFF AFTER COLLECTING BLOOD. THIS OCCURRED WHILE THE PHLEBOTOMIST WAS MIXING THE TUBE. THIS HAPPENED THREE TIMES. NO SERIOUS INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853054 BD VACUTAINER® PLUS PLASTIC SST TUBE. GOLD BD HEMOGARD¿ BLOOD COLLECTION TUBE JKA BECTON, DICKINSON & CO., (BD) 6050838 00382903679867

    Patients

    Seq Age Sex Outcome Treatment
    1 Other